3D Visualization System
Model 3DVS-S100B · Scivita Medical Technology Co., Ltd. · DI 06971381250022
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.42 |
| 2019-02 | 0 | 3.53 |
| 2019-03 | 0 | 2.95 |
| 2019-04 | 0 | 3.13 |
| 2019-05 | 0 | 2.46 |
| 2019-06 | 0 | 3.58 |
| 2019-07 | 0 | 2.42 |
| 2019-08 | 0 | 2.47 |
| 2019-09 | 0 | 2.47 |
| 2019-10 | 0 | 2.71 |
| 2019-11 | 0 | 2.12 |
| 2019-12 | 0 | 2.35 |
| 2020-01 | 0 | 2.55 |
| 2020-02 | 0 | 2.7 |
| 2020-03 | 0 | 2.28 |
| 2020-04 | 0 | 2.54 |
| 2020-05 | 0 | 1.98 |
| 2020-06 | 0 | 2.78 |
| 2020-07 | 0 | 2.77 |
| 2020-08 | 0 | 4.33 |
| 2020-09 | 0 | 4.4 |
| 2020-10 | 0 | 3.99 |
| 2020-11 | 0 | 4.47 |
| 2020-12 | 0 | 3.87 |
| 2021-01 | 0 | 3.99 |
| 2021-02 | 0 | 3.89 |
| 2021-03 | 0 | 4.83 |
| 2021-04 | 0 | 4.7 |
| 2021-05 | 0 | 4.05 |
| 2021-06 | 0 | 4.28 |
| 2021-07 | 0 | 3.88 |
| 2021-08 | 0 | 3.87 |
| 2021-09 | 0 | 3.91 |
| 2021-10 | 0 | 3.99 |
| 2021-11 | 0 | 3.49 |
| 2021-12 | 0 | 4.46 |
| 2022-01 | 0 | 4.57 |
| 2022-02 | 0 | 5.03 |
| 2022-03 | 0 | 5.45 |
| 2022-04 | 0 | 6.48 |
| 2022-05 | 0 | 5.46 |
| 2022-06 | 0 | 6.07 |
| 2022-07 | 0 | 6.34 |
| 2022-08 | 0 | 6.38 |
| 2022-09 | 0 | 5.53 |
| 2022-10 | 0 | 5.35 |
| 2022-11 | 0 | 5.52 |
| 2022-12 | 0 | 6 |
| 2023-01 | 0 | 5.73 |
| 2023-02 | 0 | 4.87 |
| 2023-03 | 0 | 5.86 |
| 2023-04 | 0 | 5.47 |
| 2023-05 | 0 | 5.86 |
| 2023-06 | 0 | 7.1 |
| 2023-07 | 0 | 6.1 |
| 2023-08 | 0 | 6.28 |
| 2023-09 | 0 | 5.92 |
| 2023-10 | 0 | 6.38 |
| 2023-11 | 0 | 5.76 |
| 2023-12 | 0 | 6.05 |
| 2024-01 | 0 | 5.53 |
| 2024-02 | 0 | 6.18 |
| 2024-03 | 0 | 5.56 |
| 2024-04 | 0 | 6.32 |
| 2024-05 | 0 | 5.3 |
| 2024-06 | 0 | 7.07 |
| 2024-07 | 0 | 5.75 |
| 2024-08 | 0 | 6.5 |
| 2024-09 | 0 | 6.28 |
| 2024-10 | 0 | 7.11 |
| 2024-11 | 0 | 4.55 |
| 2024-12 | 0 | 4.77 |
| 2025-01 | 0 | 4.42 |
| 2025-02 | 0 | 4.03 |
| 2025-03 | 0 | 5.17 |
| 2025-04 | 0 | 4.67 |
| 2025-05 | 0 | 4.69 |
| 2025-06 | 0 | 4.58 |
| 2025-07 | 0 | 4.68 |
| 2025-08 | 0 | 5.45 |
| 2025-09 | 0 | 3.97 |
| 2025-10 | 0 | 4.59 |
| 2025-11 | 0 | 4.86 |
| 2025-12 | 0 | 6.15 |
| 2026-01 | 0 | 4.95 |
| 2026-02 | 0 | 5.05 |
| 2026-03 | 0 | 5.77 |
| 2026-04 | 0 | 6.2 |
| 2026-05 | 0 | 5.86 |
| 2026-06 | 0 | 5.01 |
Regulatory clearances
- K183675 SESE 2019-09-25 (k number procode)
Predicate lineage
K183675 — cites (transitively): K072387 (d1), K113203 (d1), K121959 (d1), K123365 (d1), K131953 (d1), K934559 (d1), K102379 (d2), K051645 (d2), K061313 (d2), K062049 (d2), K100584 (d2), K111425 (d2), K112680 (d2), K070716 (d2), K943304 (d3), K943307 (d3), K080948 (d3), K002749 (d3), K011151 (d3)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Scivita Medical Technology Co., Ltd.
- VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations
- VAI 2025-04-10 SCIVITA MEDICAL TECHNOLOGY CO LTD · 0 citations